The FDA is reporting a Class I recall for ResMed’s Stellar 100 and Stellar 150 noninvasive/invasive ventilators, which are used for adult and pediatric patients who are non-ventilator dependent and spontaneously breathing.
According to the FDA, the device’s sound alarm may fail to work if it has a failed electronic part, if it is stored without AC power connected for more than 36 hours letting the battery drain completely, or if the device powers on automatically when connected to AC power without pressing the power switch.
The FDA reported one death due to use of affected Stellar ventilators, according to an agency recall alert. The FDA warns that using affected devices may cause serious adverse health consequences, including risk of serious injury or death.
Healthcare providers are urged to do the following:
- Do not use affected Stellar ventilators in patients that cannot have any breaks in breathing support or need a ventilator for life support.
- Perform a functional test that includes the use of alarms prior to each use. See Stellar User Guide for more informations.
- Press the power switch at the back of the device one time to turn on the device.
- Check that the alarm sounds a test beep.
- There will be a visual indicator (LEDs) for the alarm signal and the alarm mute button will flash.
- Continue to follow all patient and device information in the Stellar User and Clinical Guides, with a focus on these sections:
- Functional test
- Working with alarms
- Internal battery
- Mobile use
The FDA recommended contacting ResMed with questions on any devices: 855-245-4640 or firstname.lastname@example.org.